Software Validation for Medical Devices

Software Validation for Medical Devices

Course Objective:

  • General requirements for Software Validation
  • The linkage of the Software Validation with the standards and regulatory requirements
  • Step-by-step on performing the Software Validation.
  • Hands on experience to develop Software Validation documentation

Course Highlight:

  • Overview on the software validation / computer software application validation for medical devices industry.
  • Linkage of the software validation with the international standard and regulatory requirements
  • What is included in the scope of software validation?
  • Do we need to perform the IQ/OQ/PQ during the software validation
  • How to write a software validation protocol?
  • Practical activities in software validation protocol generation
  • When to re-validate the software?

Duration:

1 day

Suitable for:

Any person whom would like to gain the knowledge on the software validation / computer software application validation for medical devices.

Contact us for the synopsis.


课程亮点:
  • 什么是软件验证?
  • 软件验证相关的国际标准和法规要求
  • 软件验证的范围包括了什么软件呢?
  • 在软件验证当中,我们需要执行IQ/OQ/PQ的方案吗?
  • 怎样撰写软件验证的方案呢?
  • 实际的练习如何撰写软件验证方案
  • 什么时候需要再度执行软件验证呢?
为期:
一天

适合人群:
任何想要获取医疗器械软件验证知识的人士。

请联络我们来获取全面的课程资讯。

备注:我们的培训导师可以使用中文来进行培训。


Software Validation for Medical Devices

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